A Randomized Trial to Study the Safety and Efficacy of EGF Cancer Vaccination in Late-stage (IIIB/IV) Non-small Cell Lung Cancer Patients (NSCLC)

This study has been terminated.
(The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population & to further strengthen OS benefit)
Sponsor:
Information provided by (Responsible Party):
Bioven Sdn. Bhd. ( Bioven Europe )
ClinicalTrials.gov Identifier:
NCT01444118
First received: September 29, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The vaccine contains humanized recombinant antigen (Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase III clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase III trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IIIB/IV NSCLC patients compared to standard treatment and supportive care.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Biological: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Official Title: Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and Efficacy of an EGF Cancer Vaccine in Inoperable, Late Stage (IIIb/IV) NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care.

Resource links provided by NLM:


Further study details as provided by Bioven Sdn. Bhd.:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Each patient will be followed till death occurs within the time frame of study of 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the safety of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients. [ Time Frame: Each patients will be followed till death occurs within the time frame of study of 3 years ] [ Designated as safety issue: Yes ]

Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGF Vaccine
Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
Biological: Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)
Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
No Intervention: Best Supportive Care
Patients in this arm will receive best supportive care

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are aged 20-65 years (inclusive).
  2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Have adequate bone marrow, liver and renal function, as assessed by the Investigator. A sample taken at Screening should confirm that:

    • White blood cell (WBC) count ≥ 3000 per µL
    • Platelet count ≥ 100,000 per µL
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN when liver metastases are present)
    • Total bilirubin ≤ 1.5 x ULN
    • Serum creatinine ≤ 1.5 x ULN
  4. Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV [as defined by the American Joint Committee on Cancer staging system]), excluding brain metastases.
  5. Are eligible to receive first-line chemotherapy (without concurrent thoracic radiotherapy or consolidation radiotherapy).
  6. Agree to use double-barrier contraception (males and females alike [if applicable]). A negative pregnancy test must be documented at Screening for females of childbearing potential.

    Note: Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile, while post-menopausal refers to those women with at least 2 years from last menstruation.

  7. Have signed a voluntary written informed consent form (ICF). Patients should be cooperative, willing and able to participate and adhere to the Protocol requirements, including their availability for the follow-up.

Exclusion Criteria:

  1. Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
  2. Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic radiotherapy.
  3. Patient has a history of known or suspected central nervous system (CNS) metastases.
  4. Patient has a history of primary malignancy (except resected non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix), unless in complete remission and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5 years.
  5. Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Use is not permitted within 1 month before Screening.
  6. Patient is taking any other immunotherapy.
  7. Patient has primary or secondary immunodeficiencies (e.g. documented Human Immunodeficiency Virus [HIV]).
  8. Patient has autoimmune disease.
  9. Patient has undergone splenectomy.
  10. Patient is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month before Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), or topical steroids are permitted.
  11. Patient has a neurotoxicity (Grade ≥2).
  12. Patient has diarrhoea (Grade ≥2).
  13. Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
  14. Patient has a history of any severe or life-threatening hypersensitivity reaction.
  15. Patient has an unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease).
  16. Patient has recent history (within 6 months before Screening) of chronic alcohol or drug abuse which may compromise the patient's safety or ability to participate in study activities.
  17. Patient has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions.
  18. Patient is currently enrolled in an investigational device or drug trial, or <1 month since completing an investigational device or drug trial.
  19. Female patients who are pregnant or lactating.
  20. Patient has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444118

Locations
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Sponsors and Collaborators
Bioven Europe
Investigators
Principal Investigator: Marianne Nicolson, Dr. Aberdeen Royal Infirmary UK
  More Information

No publications provided

Responsible Party: Bioven Sdn. Bhd. ( Bioven Europe )
ClinicalTrials.gov Identifier: NCT01444118     History of Changes
Other Study ID Numbers: BV-NSCLC-001
Study First Received: September 29, 2011
Last Updated: March 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cyclophosphamide
Freund's Adjuvant
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 15, 2014